CN103271993B - Liquid preparation for rhinitis/allergic rhinitis as well as preparation method and application thereof - Google Patents
Liquid preparation for rhinitis/allergic rhinitis as well as preparation method and application thereof Download PDFInfo
- Publication number
- CN103271993B CN103271993B CN201310197676.XA CN201310197676A CN103271993B CN 103271993 B CN103271993 B CN 103271993B CN 201310197676 A CN201310197676 A CN 201310197676A CN 103271993 B CN103271993 B CN 103271993B
- Authority
- CN
- China
- Prior art keywords
- rhinitis
- extract
- preparation
- allergic rhinitis
- liquid preparation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention relates to the technical field of liquid traditional Chinese medicine preparations and provides a liquid preparation for rhinitis/allergic rhinitis as well as a preparation method and application thereof. The liquid preparation is obtained by virtue of the following method: carrying out centrifugation after dissolving Artemisia rupetris extracts in a solubilizer solution, taking the supernatant, adding Scutellaria baicalensis extracts to the supernatant and completely dissolving the Scutellaria baicalensis extracts; then adding a thickener solution to the solution, mixing the solutions uniformly, then adding liquorice extracts to the mixture, stirring the mixture to dissolve the liquorice extracts, then adding a preservative to the solution, and fully stirring the solution to dissolve the preservative; and finally adding water for injection to the solution and mixing the substances uniformly, thus obtaining the liquid preparation for rhinitis/allergic rhinitis. The liquid preparation is simple in process, has stable and controllable quality, obvious curative effects and no toxic or side effect, directly acts on the surface of nasal mucosa, has high bioavailability, takes effect quickly, is convenient to use and has good patient compliance.
Description
Technical field
the present invention relates to liquid preparation of Chinese medicine technical field, is a kind of rhinitis/allergic rhinitis liquid preparation and its preparation method and application.
Background technology
allergic rhinitis is common anaphylactic disease, be a kind of repeated relapsing with sneeze, water sample thin nasal discharge, have a stuffy nose as the chronic nasal mucosa inflammation of principal character.This disease often causes the harmful effects such as sleep quality declines, emotion is irritated, dejected, and daily routines and social communication are subject to certain restrictions.If allergic rhinitis generation drug reaction or various complication (sinusitis, nasal polyp, otitis media, asthma etc.), make the matter worse especially.Due to the seriality that upper respiratory tract and lower respiratory tract are dissected, upper respiratory tract infection spreads very easily downwards, many patient Chang Xianhou or simultaneously trouble allergic rhinitis and bronchial asthma.In Allergic Rhinitis, asthma prevalence calibration ordinary person is high 4 times to 20 times, and even 60% allergic rhinitis may develop into asthma.
therapeutic Method the most frequently used is at present pharmacotherapy.Doctor trained in Western medicine is many treats from aspects such as symptomatic treatment and reduction body sensitivity, but late result is still undesirable and side effect is comparatively large, and doctor trained in Western medicine common drug has: antihistaminic class (as chlorphenamine, Cyproheptadine, hismanal etc.), steroid hormone (as prednisone, budesonide, dexamethasone etc.), external nasal drop (1% ephedrine nasal drop and 0.5% cortisone collyrium collunarium etc.).
the dry root that Radix Scutellariae (Scutellaria baiacelnsis Georgi.) is labiate Radix Scutellariae, begin to be loaded in Shennong's Herbal, cold in nature, bitter in the mouth, has the effects such as eliminating fire and detoxication.Main chemical compositions is flavones ingredient, and baicalin (Baicalin) is topmost active component.Research report Radix Scutellariae has very strong antiinflammatory action.
herba Achilleae (Artemisia rupestris L.) is the whole plant for medical use of Compositae artemisia herbaceos perennial Herba Achilleae.Be Kazak and Uygur nationality's medicinal herbs most in use, medication among the people is with a long history is used for the treatment of urticaria, pharyngitis, tonsillitis etc.Research shows, Herba Achilleae extract has stronger anti-inflammatory activity.
the dry root welding technology of Radix Glycyrrhizae system glycyrrhizic legume Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. Glycyrrhiza glabra L..Main chemical compositions triterpenes and flavonoid, wherein triterpenes components has glycyrrhizic acid.Because the glycyrrhizic acid in Radix Glycyrrhizae is structurally similar to glucocorticoid, the metabolism of 17-hydroxy-11-dehydrocorticosterone can be delayed in vivo, and hypothalamus-pituitary-thyroid axis is had no significant effect, at present for dermatitis, anti-inflammatory treatment that drug eruption is relevant.
Summary of the invention
the invention provides a kind of rhinitis/allergic rhinitis liquid preparation and its preparation method and application, overcome the deficiency of above-mentioned prior art, its can effectively solve current doctor trained in Western medicine for the curative effect of rhinitis/allergic rhinitis the still undesirable and problem that side effect is large.
one of technical scheme of the present invention is realized by following measures: a kind of rhinitis/allergic rhinitis liquid preparation, water for injection containing Radix Scutellariae extract 10g to 20g, Herba Achilleae extract 10g to 20g, Radix Glycyrrhizae extract 5g to 11 g, solubilizing agent 1g to 7 g, thickening agent 0.5g to 3.5 g, surplus in every 100ml rhinitis/allergic rhinitis liquid preparation comprises shot water and biphasic injection water, the water for injection of antiseptic 0.02g to 0.20 g and surplus, wherein, this rhinitis/allergic rhinitis liquid preparation obtains as follows: the solubilizing agent of aequum and thickening agent are dissolved in shot water first respectively and obtain solubilizer solution and thickener soln respectively, carry out centrifugal after Herba Achilleae extract solubilizer solution is dissolved, get supernatant, in supernatant, add Radix Scutellariae extract and Radix Scutellariae extract is dissolved completely, then thickener soln mix homogeneously is added wherein, add Radix Glycyrrhizae extract stirring more wherein to dissolve, then the antiseptic of aequum is added wherein, rhinitis/allergic rhinitis liquid preparation is obtained after finally adding biphasic injection water mix homogeneously wherein after abundant stirring and dissolving.
two of technical scheme of the present invention is realized by following measures: the preparation method of a kind of rhinitis/allergic rhinitis liquid preparation, the water for injection containing Radix Scutellariae extract 10g to 20g, Herba Achilleae extract 10g to 20g, Radix Glycyrrhizae extract 5g to 11 g, solubilizing agent 1g to 7 g, thickening agent 0.5g to 3.5 g, antiseptic 0.02g to 0.20 g and surplus in every 100ml rhinitis/allergic rhinitis liquid preparation, wherein, the preparation method of this rhinitis/allergic rhinitis liquid preparation is carried out in the steps below: the water for injection of surplus comprises shot water and biphasic injection water, first respectively the solubilizing agent of aequum and thickening agent are dissolved in shot water and obtain solubilizer solution and thickener soln respectively, carry out centrifugal after Herba Achilleae extract solubilizer solution is dissolved, get supernatant, in supernatant, add Radix Scutellariae extract and Radix Scutellariae extract is dissolved completely, then thickener soln mix homogeneously is added wherein, add Radix Glycyrrhizae extract stirring more wherein to dissolve, then the antiseptic of aequum is added wherein, rhinitis/allergic rhinitis liquid preparation is obtained after finally adding biphasic injection water mix homogeneously wherein after abundant stirring and dissolving.
here is the further optimization and/or improvements to foregoing invention technical scheme:
above-mentioned Herba Achilleae extract obtains by following preparation method: carry out alcohol extraction 1 time to 5 times by adding ethanol water in Herba Achilleae medical material, each alcohol extraction by add in every gram of Herba Achilleae medical material mass concentration be 30% to 95% ethanol water 6ml to 14ml in Herba Achilleae medical material, add ethanol water, time of each alcohol extraction is 0.5 little of 3 hours, alcohol extraction temperature is 60 DEG C to 80 DEG C, merge the alcohol extract at every turn obtained and obtain alcohol extraction conjunction liquid, then alcohol extraction is closed liquid and carry out volatilization ethanol, it is 40 DEG C to 70 DEG C in temperature that liquid is closed in alcohol extraction after volatilization ethanol, pressure is carry out drying under reduced pressure under the condition of-0.07 Mpa to-0.09Mpa to obtain the Herba Achilleae extract that biodiversity content is 5% to 20%.
above-mentioned solubilizing agent is sodium bicarbonate or sodium hydroxide; Or/and thickening agent is methylcellulose or Carbopol or carboxymethyl cellulose; Or/and antiseptic is Nipagin ester, during use, first Nipagin ester is dissolved in dehydrated alcohol and obtains Nipagin ester ethanol solution, then use.
above-mentioned Radix Scutellariae extract obtains by the preparation method described in the Radix Scutellariae extract in Chinese Pharmacopoeia version first in 2010; Or/and the preparation method described in Radix Glycyrrhizae extractum in Radix Glycyrrhizae extract Chinese Pharmacopoeia version first in 2010 obtains.
three of technical scheme of the present invention is realized by following measures: a kind of rhinitis/allergic rhinitis liquid preparation is in the application in preparation treatment rhinitis/allergic rhinitis object space face.
here is the further optimization and/or improvements to foregoing invention technical scheme three:
above-mentioned treatment rhinitis/allergic rhinitis medicine is drop or injectant or detergent.
present invention process is simple, and constant product quality is controlled, and curative effect is obvious, and have no side effect, medicine directly acts on nasal mucosal surface, and bioavailability is high, rapid-action, easy to use, patient compliance is good.
Accompanying drawing explanation
fig. 1 is the nasal mucosa pathological section figure (HE × 200) of Normal group AR Cavia porcellus.
fig. 2 is the nasal mucosa pathological section figure (HE × 200) of model group AR Cavia porcellus.
fig. 3 is the nasal mucosa pathological section figure (HE × 200) of blank group group AR Cavia porcellus.
fig. 4 is the nasal mucosa pathological section figure (HE × 200) of positive controls AR Cavia porcellus.
fig. 5 is the nasal mucosa pathological section figure (HE × 200) of the low dose group AR Cavia porcellus of rhinitis of the present invention/allergic rhinitis liquid preparation.
fig. 6 is the nasal mucosa pathological section figure (HE × 200) of dosage group AR Cavia porcellus in rhinitis of the present invention/allergic rhinitis liquid preparation.
fig. 7 is the nasal mucosa pathological section figure (HE × 200) of the high dose group AR Cavia porcellus of rhinitis of the present invention/allergic rhinitis liquid preparation.
fig. 8 is Normal group AR guinea-pig nasal mucosa pathology slice map (toluidine blue × 400).
fig. 9 is model group AR guinea-pig nasal mucosa pathology slice map (toluidine blue × 400).
figure 10 is blank group AR guinea-pig nasal mucosa pathology slice map (toluidine blue × 400).
figure 11 is positive controls AR guinea-pig nasal mucosa pathology slice map (toluidine blue × 400).
figure 12 is low dose group AR guinea-pig nasal mucosa pathology slice map (toluidine blue × 400) of rhinitis of the present invention/allergic rhinitis liquid preparation.
figure 13 is dosage group AR guinea-pig nasal mucosa pathology slice map (toluidine blue × 400) in rhinitis of the present invention/allergic rhinitis liquid preparation.
figure 14 is high dose group AR guinea-pig nasal mucosa pathology slice map (toluidine blue × 400) of rhinitis of the present invention/allergic rhinitis liquid preparation.
figure 15 is Normal group AR Rat Nasal Mucosa pathological section figure (HE × 200).
figure 16 is model group AR Rat Nasal Mucosa pathological section figure (HE × 200).
figure 17 is blank group AR Rat Nasal Mucosa pathological section figure (HE × 200).
figure 18 is positive controls AR Rat Nasal Mucosa pathological section figure (HE × 200).
figure 19 is low dose group AR Rat Nasal Mucosa pathological section figure (HE × 200) of rhinitis of the present invention/allergic rhinitis liquid preparation.
figure 20 is dosage group AR Rat Nasal Mucosa pathological section figure (HE × 200) in rhinitis of the present invention/allergic rhinitis liquid preparation.
figure 21 is high dose group AR Rat Nasal Mucosa pathological section figure (HE × 200) of rhinitis of the present invention/allergic rhinitis liquid preparation.
figure 22 is Normal group AR Rat Nasal Mucosa pathological section figure (toluidine blue × 400).
figure 23 is for being model group AR Rat Nasal Mucosa pathological section figure (toluidine blue × 400).
figure 24 is blank group AR Rat Nasal Mucosa pathological section figure (toluidine blue × 400).
figure 25 is positive controls AR Rat Nasal Mucosa pathological section figure (toluidine blue × 400).
figure 26 is low dose group AR Rat Nasal Mucosa pathological section figure (toluidine blue × 400) of rhinitis of the present invention/allergic rhinitis liquid preparation.
figure 27 is dosage group AR Rat Nasal Mucosa pathological section figure (toluidine blue × 400) in rhinitis of the present invention/allergic rhinitis liquid preparation.
figure 28 is high dose group AR Rat Nasal Mucosa pathological section figure (toluidine blue × 400) of rhinitis of the present invention/allergic rhinitis liquid preparation.
Detailed description of the invention
the present invention by the restriction of following embodiment, can not determine concrete embodiment according to technical scheme of the present invention and practical situation.
below in conjunction with embodiment, the invention will be further described:
embodiment 1, this rhinitis/allergic rhinitis liquid preparation, the water for injection containing Radix Scutellariae extract 10g to 20g, Herba Achilleae extract 10g to 20g, Radix Glycyrrhizae extract 5g to 11 g, solubilizing agent 1g to 7 g, thickening agent 0.5g to 3.5 g, antiseptic 0.02g to 0.20 g and surplus in every 100ml rhinitis/allergic rhinitis liquid preparation, wherein, this rhinitis/allergic rhinitis liquid preparation obtains by following preparation method: the water for injection of surplus comprises shot water and biphasic injection water, first respectively the solubilizing agent of aequum and thickening agent are dissolved in shot water and obtain solubilizer solution and thickener soln respectively, carry out centrifugal after Herba Achilleae extract solubilizer solution is dissolved, get supernatant, in supernatant, add Radix Scutellariae extract and Radix Scutellariae extract is dissolved completely, then thickener soln mix homogeneously is added wherein, add Radix Glycyrrhizae extract stirring more wherein to dissolve, then the antiseptic of aequum is added wherein, rhinitis/allergic rhinitis liquid preparation is obtained after finally adding biphasic injection water mix homogeneously wherein after abundant stirring and dissolving.Due to the poorly water-soluble of Radix Scutellariae extract and Herba Achilleae extract, therefore need solubilizing agent be added, increase its dissolubility, for increasing the adhesion of invention formulation at nasal cavity, prolong drug, in the holdup time of nasal mucosa, strengthens drug effect, thickening agent need be added, liquid preparation of the present invention, for repeatedly to use dosage form, needs in prescription to add antiseptic, prevents growing of microorganism.
embodiment 2, this rhinitis/allergic rhinitis liquid preparation, the water for injection containing Radix Scutellariae extract 10g or 20g, Herba Achilleae extract 10g or 20g, Radix Glycyrrhizae extract 5g or 11 g, solubilizing agent 1g or 7 g, thickening agent 0.5g or 3.5 g, antiseptic 0.02g or 0.20 g and surplus in every 100ml rhinitis/allergic rhinitis liquid preparation, wherein, this rhinitis/allergic rhinitis liquid preparation obtains by following preparation method: the water for injection of surplus comprises shot water and biphasic injection water, first respectively the solubilizing agent of aequum and thickening agent are dissolved in shot water and obtain solubilizer solution and thickener soln respectively, carry out centrifugal after Herba Achilleae extract solubilizer solution is dissolved, get supernatant, in supernatant, add Radix Scutellariae extract and Radix Scutellariae extract is dissolved completely, then thickener soln mix homogeneously is added wherein, add Radix Glycyrrhizae extract stirring more wherein to dissolve, then the antiseptic of aequum is added wherein, rhinitis/allergic rhinitis liquid preparation is obtained after finally adding biphasic injection water mix homogeneously wherein after abundant stirring and dissolving.
embodiment 3, preferred as above-described embodiment, Herba Achilleae extract obtains by following preparation method: carry out alcohol extraction 1 time to 5 times by adding ethanol water in Herba Achilleae medical material, each alcohol extraction by add in every gram of Herba Achilleae medical material mass concentration be 30% to 95% ethanol water 6ml to 14ml in Herba Achilleae medical material, add ethanol water, time of each alcohol extraction is 0.5 little of 3 hours, alcohol extraction temperature is 60 DEG C to 80 DEG C, merge the alcohol extract at every turn obtained and obtain alcohol extraction conjunction liquid, then alcohol extraction is closed liquid and carry out volatilization ethanol, it is 40 DEG C to 70 DEG C in temperature that liquid is closed in alcohol extraction after volatilization ethanol, pressure is carry out drying under reduced pressure under the condition of-0.07 Mpa to-0.09Mpa to obtain the Herba Achilleae extract that biodiversity content is 5% to 20%.
embodiment 4, preferred as above-described embodiment, solubilizing agent is sodium bicarbonate or sodium hydroxide; Or/and thickening agent is methylcellulose or Carbopol or carboxymethyl cellulose; Or/and antiseptic is Nipagin ester, during use, first Nipagin ester is dissolved in dehydrated alcohol and obtains Nipagin ester ethanol solution, then use.With ciliary toxicity test and rheological properties for index select that the suitableeest thickening agent is methylcellulose, Carbopol or carboxymethyl cellulose, liquid preparation of the present invention is aqueous solution, tool surface activity, therefore selects best antiseptic to be pH to be the parabens of 4 to 8.
embodiment 5, preferred as above-described embodiment, Radix Scutellariae extract obtains by the preparation method described in the Radix Scutellariae extract in Chinese Pharmacopoeia version first in 2010; Or/and the preparation method described in Radix Glycyrrhizae extractum in Radix Glycyrrhizae extract Chinese Pharmacopoeia version first in 2010 obtains.
embodiment 6, this rhinitis/allergic rhinitis liquid preparation is in the application in preparation treatment rhinitis/allergic rhinitis object space face.
embodiment 7, preferred as above-described embodiment, treatment rhinitis/allergic rhinitis medicine is drop or injectant or detergent.
the drug effect of the rhinitis obtained according to the above embodiment of the present invention/allergic rhinitis liquid preparation is proved:
one, rhinitis of the present invention/allergic rhinitis liquid preparation xylol causes the inhibitory action of mice ear
1.1, grouping and administration
get Kunming mouse 60, male and female half and half, body weight 18 ~ 22g, be divided into 6 groups at random according to sex, body weight, often organize 10, be divided into following several groups:
model group: extract 20 μ L normal saline with microsyringe and carry out administration in the mode of collunarium, every side 10 μ L, every day 2 times, the morning and each 1 time of afternoon, for three days on end;
blank group: according to the blank medication of experimental technique of the present invention when not adding Herba Achilleae extract, Radix Scutellariae extract and Radix Glycyrrhizae extract, extract the blank medication of 20 μ L with microsyringe and carry out administration in the mode of collunarium, every side 10 μ L, every day 2 times, the morning and each 1 time of afternoon, for three days on end;
positive controls: select a classical line anti-inflammatory drug dexamethasone as positive control drug, the antiinflammatory action of this liquid preparation more can be described, in Mus ear unit are, the dosage of even spread is drafted as 0.04g/cm
2
, every day 2 times, the morning and each 1 time of afternoon, for three days on end;
high dose group: rhinitis of the present invention/allergic rhinitis liquid preparation being concentrated into volume is after 0.5 times of original volume, extracts 20 μ L and carries out administration in the mode of collunarium, every side 10 μ L, every day 2 times with microsyringe, the morning and each 1 time of afternoon, for three days on end;
middle dosage group: extract 20 μ L with microsyringe and rhinitis of the present invention/allergic rhinitis liquid preparation is carried out administration in the mode of collunarium, every side 10 μ L, every day 2 times, the morning and each 1 time of afternoon, for three days on end;
low dose group: rhinitis of the present invention/allergic rhinitis liquid preparation being diluted with water to volume is after 2 times of original volume, extracts 20 μ L and carries out administration in the mode of collunarium, every side 10 μ L, every day 2 times with microsyringe, the morning and each 1 time of afternoon, for three days on end;
after last administration 1h, warm water wipes mouse ear medicine, cleans with dry cotton ball, and 0.02mL dimethylbenzene uniform application is caused inflammation in the wide two sides of mouse right ear, compare with left ear, after 15min, de-cervical vertebra puts to death mice, cuts two ears, lay round auricle respectively with diameter 7mm card punch at the same position of two ears along auricle baseline, precise weighing (being accurate to 0.0001g), calculate swelling and inhibitory rate of intumesce, experimental result is in Table 1(n=10, ± SD).
swelling=auris dextra sheet weight-left auricle weight
inhibitory rate of intumesce={ (the average swelling of model group-average swelling of administration group) the average swelling of/model group } × 100%
note: because the nasal cavity of mice is very little, nasal cavity finite volume, in experiment, can not adopt spray nose form to mice medication, and the mode that can only extract the medicinal liquid collunarium of respective volume with microsyringe carries out administration.
, result of the test shows: blank nasal drop group compare with model group there was no significant difference (
p>0.05), without antiinflammatory action; The inhibitory action that these basic, normal, high three dosage group xylol cause mice ear and model group more all have significant difference (
p<0.01), and high dose group compares antiinflammatory action quite with Dexamethasone group, there was no significant difference (
p>0.05), illustrate that rhinitis of the present invention/allergic rhinitis liquid preparation has significant antiinflammation.
two, rhinitis of the present invention/allergic rhinitis liquid preparation is to the inhibitory action of allotransplantation in rats passive cutaneous anaphylaxis, PCA (PCA)
2.1, grouping and administration: get rat 60, male and female half and half, be divided into 6 groups at random according to sex, often organizes 10, and by following administration:
model group: extract 20 μ L normal saline with microsyringe and carry out administration in the mode of collunarium, every side 10 μ L, every day 2 times, the morning and each 1 time of afternoon, for three days on end;
blank group: according to the blank medication of experimental technique of the present invention when not adding Herba Achilleae extract, Radix Scutellariae extract and Radix Glycyrrhizae extract, extract the blank medication of 20 μ L with microsyringe and carry out administration in the mode of collunarium, every side 10 μ L, every day 2 times, the morning and each 1 time of afternoon, for three days on end;
positive controls: select a classical line Claritin chlorphenamine as positive control drug, dosage is 0.107m g/kgd, and administering mode is gastric infusion, for three days on end;
high dose group: rhinitis of the present invention/allergic rhinitis liquid preparation being concentrated into volume is after 0.5 times of original volume, extracts 20 μ L and carries out administration in the mode of collunarium, every side 10 μ L, every day 2 times with microsyringe, the morning and each 1 time of afternoon, for three days on end;
middle dosage group: extract 20 μ L with microsyringe and rhinitis of the present invention/allergic rhinitis liquid preparation is carried out administration in the mode of collunarium, every side 10 μ L, every day 2 times, the morning and each 1 time of afternoon, for three days on end;
low dose group: rhinitis of the present invention/allergic rhinitis liquid preparation being diluted with water to volume is after 2 times of original volume, extracts 20 μ L and carries out administration in the mode of collunarium, every side 10 μ L, every day 2 times with microsyringe, the morning and each 1 time of afternoon, for three days on end;
note: because the nasal cavity of rat is very little, nasal cavity finite volume, in experiment, can not adopt spray nose form to mice medication, and the mode that can only extract the medicinal liquid collunarium of respective volume with microsyringe carries out administration.
, sero-fast preparation: 1. rat body basis sensitization: (every milliliter containing ovalbumin 1mg subcutaneous for subcutaneous for rat both sides groin, the left and right hind leg foot sole of the foot and abdominal cavity respectively to be injected the antigen adjuvant suspension of 0.2ml, aluminium hydroxide 30mg) sensitization, the same manner strengthening sensitization is pressed in the 5th day, lumbar injection 1ml antigen adjuvant suspension in starting for the 2nd day next day the simultaneously, totally 7 times; 2. rat nose excites: after whole body prime immunization completes, and the attack of intranasal antigen is carried out, every side 50 μ l in 2% ovalbumin normal saline solution instillation bilateral nostril by secondary daily microsyringe, and every day 1 time, continuous 5d, causes allergic rhinitis model rat model; Get allergic rhinitis model rat 5, in the 14(IgE height agent time) huge rathole socket of the eye gets blood, the centrifugal 15min of 2500rmin-1, and separation of serum also merges, and puts-20 DEG C of refrigerators, for subsequent use in 2 weeks.
, hair (every side 3cm × 4cm) is shaved apart from spinal column 1.5 ~ 2.0cm place in each group of rat back center line both sides, by above-mentioned antiserum normal saline dilution 1:5 and 1:10 during experiment, back intradermal injection (model group is sensitization not), each dilution factor injects 2 points, often some 0.1ml, interval 1.5cm to 2 cm; Each group all started administration in sensitization the same day, carry out administration according to administering mode described in 2.1, after 48 h (namely after last administration 1h), tail vein injection 1ml(includes 1mg ovalbumin) 1% Evans Blue solution (dyestuff), after 30min, de-neck puts to death (anesthesia is put to death) rat, upset skin of back, cuts the skin (providing locus coeruleus photo) with blueness, shreds, insert and fill 5ml acetone-normal saline (7:3 V/V), whirlpool mixes, and in vitro soaks 48 h, 2500 rmin -1 , centrifugal 10min, gets supernatant and measures absorbance (A) in 610nm place, and calculate medicine to PCA inhibition percentage, experimental result is in Table2 (n=10,
± SD).
inhibition percentage [suppression ratio %=(1-administration group/model group) × 100%]
2.4, result of the test shows: model group compares with blank group, and there was no significant difference (P>0.05), without obvious anti-allergic effects; Low, middle dosage group compares with model group type, there was no significant difference; High dose group compares with model group significant difference (P < 0.05), but chlorphenamine sheet is compared the inhibitory action that P of Rats CA reacts compared with positive controls certain diversity (P < 0.05), but it is possible to illustrate that rhinitis of the present invention/allergic rhinitis liquid preparation high dose group has certain antianaphylaxis.
three, this liquid preparation is to the inhibitory action of guinea-pig nasal mucosa capillary permeability
3.1, grouping and administration: get Cavia porcellus 60, male and female half and half, be divided into 6 groups at random according to sex, often organizes 10, and by following administration:
model group: extract 0.2ml normal saline with microsyringe and carry out administration in the mode of collunarium, every side 0.1ml;
blank group: according to the blank medication of experimental technique of the present invention when not adding Herba Achilleae extract, Radix Scutellariae extract and Radix Glycyrrhizae extract, extracts the blank medication of 0.2ml with microsyringe and carries out administration in the mode of collunarium, every side 0.1ml;
positive controls: carry out administration in the mode of collunarium, every side 0.1ml with the ephedrine solution that microsyringe extraction 0.2ml mass concentration is 1%;
high dose group: rhinitis of the present invention/allergic rhinitis liquid preparation being concentrated into volume is after 0.5 times of original volume, extracts 0.2ml with microsyringe and carries out administration in the mode of collunarium, every side 0.1ml;
middle dosage group: extract 0.2ml with microsyringe and rhinitis of the present invention/allergic rhinitis liquid preparation is carried out administration in the mode of collunarium, every side 0.1ml;
low dose group: rhinitis of the present invention/allergic rhinitis liquid preparation being diluted with water to volume is after 2 times of original volume, extracts 0.2ml with microsyringe and carries out administration in the mode of collunarium, every side 0.1ml;
note: because the nasal cavity of Cavia porcellus is very little, nasal cavity finite volume, in experiment, can not adopt spray nose form to mice medication, and the mode that can only extract the medicinal liquid collunarium of respective volume with microsyringe carries out administration.
, by each group of Cavia porcellus with after 10% chloral hydrate intraperitoneal injection of anesthesia (0.3ml/100g), be placed in flat board is lain on the back fixing.Cut off skin of upper extremity, fascia near peeling off, fully expose upper limb venae subcutaneae; 1% Evans Blue(azovan blue is injected from upper limb venae subcutaneae) physiological sodium chloride solution 4mlkg -1 , afterwards, be rapidly to each group of guinea-pig nasal intracavity respectively and carry out administration by 3.1 administering modes; 30min after injection, femoral artery sacrificed by exsanguination animal, open nasal cavity, take out bilateral nasal mucosa, the tissue normal saline of taking-up is rinsed gently, blot with filter paper, precise weighing on electronic balance, put into acetone physiological sodium chloride solution (7:3) mixed liquor 2ml, 72-96h is hatched at 45 DEG C, centrifugal, get supernatant, survey trap with spectrophotometer (610nm place), with blank acetone normal saline school zero, calculate the trap (Amg-1) of nasal mucosa unit mass, respectively organize significance with t inspection, experimental result is in Table3 (n=10,
± SD).
, result of the test shows: compare with model group, high dose group significantly can suppress capillary permeability, reduces the seepage discharge of nasal mucosa unit mass azovan blue, has antiinflammatory action, and effect suitable with the effect of positive controls vasoconstrictive (
p>0.05), illustrate that rhinitis of the present invention/allergic rhinitis liquid preparation has antiinflammatory action.
four, rhinitis of the present invention/allergic rhinitis liquid preparation is to the therapeutical effect of Cavia porcellus allergic rhinitis model
4.1, grouping: get Cavia porcellus 70, male and female half and half, be divided into 7 groups at random according to sex, often organize 10, be divided into Normal group, model group, blank group, positive controls, high dose group, middle dosage group and low dose group;
4.2, AR guinea pig model is set up
sensitization suspension: precision takes ovalbumin (OVA) 2.4mg and aluminum hydroxide solution 2.4g and is placed in 50ml centrifuge tube, add normal saline 80ml, fully stir evenly to whirlpool oscillator, suspension (on average every milliliter containing OVA 0.3mg, Al (OH) 3 30mg), often inferior to now with the current before lumbar injection
normal group: add the capable lumbar injection of 30mg aluminium hydroxide with 1ml normal saline, the next day 1 time, continuous 7 times totally 14 days, excited from the 15th day with normal saline collunarium (bilateral), every side 100 μ L, continuous 3d, cause Normal group AR model;
model group: according to 1ml/ dosage lumbar injection sensitization suspension only, the next day 1 time, continuous 7 times totally 14 days, the collunarium (bilateral) being 2% egg albumin solution with mass concentration from the 15th day excited, and every side 100 μ L, continuous 3d, cause model group AR model;
blank group: according to 1ml/ dosage lumbar injection sensitization suspension only, the next day 1 time, continuous 7 times totally 14 days, the collunarium (bilateral) being 2% egg albumin solution with mass concentration from the 15th day excites, every side 100 μ L, continuous 3d, cause blank group AR model;
positive controls: according to 1ml/ dosage lumbar injection sensitization suspension only, the next day 1 time, continuous 7 times totally 14 days, the collunarium (bilateral) being 2% egg albumin solution with mass concentration from the 15th day excites, every side 100 μ L, continuous 3d, cause positive controls AR model;
high dose group: according to 1ml/ dosage lumbar injection sensitization suspension only, the next day 1 time, continuous 7 times totally 14 days, the collunarium (bilateral) being 2% egg albumin solution with mass concentration from the 15th day excites, every side 100 μ L, continuous 3d, cause high dose group AR model;
middle dosage group: according to 1ml/ dosage lumbar injection sensitization suspension only, the next day 1 time, continuous 7 times totally 14 days, the collunarium (bilateral) being 2% egg albumin solution with mass concentration from the 15th day excites, every side 100 μ L, continuous 3d, cause middle dosage group AR model;
low dose group: according to 1ml/ dosage lumbar injection sensitization suspension only, the next day 1 time, continuous 7 times totally 14 days, the collunarium (bilateral) being 2% egg albumin solution with mass concentration from the 15th day excites, every side 100 μ L, continuous 3d, cause low dose group AR model;
4.3, administration
after modeling, administration as follows:
normal group: extract 100 μ L normal saline with microsyringe and carry out administration in the mode of collunarium, every side 50 μ L, every day 2 times, the morning and each 1 time of afternoon, continuous 7 days;
model group: extract 100 μ L normal saline with microsyringe and carry out administration in the mode of collunarium, every side 50 μ L, every day 2 times, the morning and each 1 time of afternoon, continuous 7 days;
blank group: according to the blank medication of experimental technique of the present invention when not adding Herba Achilleae extract, Radix Scutellariae extract and Radix Glycyrrhizae extract, extract the blank medication of 100 μ L with microsyringe and carry out administration in the mode of collunarium, every side 50 μ L, every day 2 times, the morning and each 1 time of afternoon, continuous 7 days;
positive controls: extracting 100 μ L mass concentrations with microsyringe is that 0.15% ketotifen fumarate carries out administration in the mode of collunarium, every side 50 μ L, every day 2 times, the morning and each 1 time of afternoon, continuous 7 days;
high dose group: rhinitis of the present invention/allergic rhinitis liquid preparation being concentrated into volume is after 0.5 times of original volume, extracts 100 μ L and carries out administration in the mode of collunarium, every side 50 μ L, every day 2 times with microsyringe, the morning and each 1 time of afternoon, continuous 7 days;
middle dosage group: extract 100 μ L with microsyringe and rhinitis of the present invention/allergic rhinitis liquid preparation is carried out administration in the mode of collunarium, every side 50 μ L, every day 2 times, the morning and each 1 time of afternoon, continuous 7 days;
low dose group: rhinitis of the present invention/allergic rhinitis liquid preparation being diluted with water to volume is after 2 times of original volume, extract 100 μ L with microsyringe and carry out administration in the mode of collunarium, every side 50 μ L, every day 2 times, the morning and each 1 time of afternoon, continuous 7 days.
above-mentioned in administration process, respectively at the 2nd, the 5th, the 7th day after morning dose 30min drip bilateral nostril to each group of rat 1g/L ovalbumin normal saline solution, the each 50 μ L in every side, bilateral equal-volume instills, and afternoon, administration was, no longer carried out nose antigen stimulation.
, nose allergic symptom observes: after each nose excites, observe 30min immediately.Observe sniffle as rhinocnesmus scratching, sneeze, watery nasal discharge.
, collection of specimens and process
4.5.1, gather: 7 groups of Cavia porcellus mass concentrations are that after chloral hydrate (0.3ml/100g) anesthesia of 10%, ventral aorta blood sampling is about 5ml to 6ml, deposit in test tube.
, serum preparation: get placement naturally under standby sample of blood liquid room temperature, after 2 hours with the rotating speed of 3000rpm centrifugal 10 minutes, pipette serum with micropipettor, put into Eppendoff pipe, be placed in-20 DEG C and save backup.Adopt immunized guinea pigs globulin E, Cavia porcellus specific IgE and Cavia porcellus IL-4 kit measurement, operate by test kit description, measure by Tecan Infinite F50 microplate reader, calculate the content of guinea pig serum IgE, ovalbumin specific IgE and IL-4 according to respective standard curve.
, nasal mucosa collection: get blood complete, after ventral aorta blood-letting is lethal, peel off nose surrounding skin at once, upper jaw bone is dissociated out from skull, fix by 10% formalin, paraffin embedding, does HE and Toluidine blue staining, light Microscopic observation nasal mucosa, mastocyte and cell infiltration situation.
, statistical method: adopt SPSS software to add up, variable data, with representing, compares between organizing, and does t inspection, and experimental result, in Table 4(, is divided,
n=6); Observe sniffle as: time that rhinocnesmus scratching, sneeze, watery nasal discharge etc. occur and weight and by following standards of grading and scoring record: rhinocnesmus: be slightly 1 point, dabbing nose is 2 points several times, and severe (scratching nose, face incessantly, scouring everywhere) is 3 points.Sneeze: 1 to 3 is 1 point, 4 to 10 is 2 points, and more than 11 is 3 points.Watery nasal discharge: flowing to anterior nares is 1 point, exceeding anterior nares is 2 points, and it is 3 points that tears stream is had one's face covered with, and remembers total score during record with the addition method.Adopt symptom integral superposition methods of marking (judging see model), compare group difference.
result of the test
4.6.1, through treatment, the allergic rhinitis sniffle average mark of ketotifen fumarate nasal drop group and high dose group obviously reduces; The sniffle integration of low, middle dosage group also decreases, through statistics, ketotifen fumarate nasal drop group and high dose group Cavia porcellus sniffle scoring all comparatively model group have obvious reduction, and between the two no difference of science of statistics (
p>0.05), low, middle dosage group symptom integral changes obviously not as good as high dose group, illustrates that rhinitis of the present invention/allergic rhinitis liquid preparation has good therapeutic effect to contingency rhinitis and allergic rhinitis.
each group of allergic rhinitis guinea pig serum IgE, specific IgE, interleukin-4 comparision contents
the content of guinea pig serum IgE, sIgE and IL-4, model group be significantly higher than Normal group (
p<0.05), this liquid preparation respectively organize comparatively model group all significantly reduce (
p<0.05); There was no significant difference between the content of low, middle dosage group SERUM IgE and IL-4 and high dose group (
p>0.05); The effect of the content of high dose group reduction guinea pig serum IgE, sIgE and IL-4 is suitable with ketotifen fumarate nasal drop group, and can find out, rhinitis of the present invention/allergic rhinitis liquid preparation has obvious antiinflammatory, anti-allergic effects, the results are shown in Table 5(
n=6).
, rhinitis of the present invention/allergic rhinitis liquid preparation is on the histological impact of guinea-pig nasal mucosa pathology
model group guinea-pig nasal mucous epithelium partial necrosis, come off, body of gland rolls up, and blood capillary is obviously expanded, congested (see figure 2), and with a large amount of acidophilia's property granulocyte, mastocyte and other cell infiltration (see figure 9)s; Structure similar to model group (see Fig. 3, Figure 10) under blank group guinea-pig nasal mucosa light microscopic; Other group lesion degrees all have alleviating in various degree: positive controls nasal epithelial is complete, in columnar arrangement, and mucosa Mild edema, interstitial blood vessel slightly expands (see figure 4), visible a small amount of inflammatory cell infiltration (see Figure 11); Low, middle dosage group nasal mucosal tissue edema, vasodilation hyperemia (see Fig. 5, Fig. 6) and eosinophilic granulocyte be main inflammatory cell infiltration situation comparatively model group make moderate progress (see Figure 12, Figure 13); High dose group nasal mucosa mild inflammation, organizes Mild edema, and part blood vessel slightly expands (see figure 7), accidental eosinophilic granulocyte, has inflammatory cell infiltration (see Figure 14) that is a small amount of, that be dispersed in; Normal group no abnormality seen (see Fig. 1, Fig. 8).
this liquid preparation each experimental group nasal mucosa histopathologic slide adds up from edema, hyperemia, inflammatory cell and mast cells infiltration situation, and result shows, Normal group total score compares with model group, have significant difference (
p<0.01); Basic, normal, high dosage group total score compares with model group, have significant difference (
p<0.01); Middle and high dosage group total score compares with positive controls, there was no significant difference (
p>0.05), can find out, rhinitis of the present invention/allergic rhinitis liquid preparation has obvious antiinflammatory, anti-allergic effects, the results are shown in Table 6(
n=6).
five, rhinitis of the present invention/allergic rhinitis liquid preparation is to the therapeutical effect of rat in allergic rhinitis model
5.1, grouping: get rat 70, male and female half and half, be divided into 7 groups at random according to sex, often organize 10, be divided into Normal group, model group, blank group, positive controls, high dose group, middle dosage group and low dose group;
5.2, AR rat model is set up
by model group, blank group, positive controls, high dose group, the rat both sides groin of middle dosage group and low dose group is subcutaneous, the antigen adjuvant suspension of 0.2ml is respectively injected in the subcutaneous and abdominal cavity of the left and right hind leg foot sole of the foot, and (every milliliter containing ovalbumin 1mg, aluminium hydroxide 30mg) sensitization, the same manner strengthening sensitization is pressed in the 5th day, lumbar injection 1ml antigen adjuvant suspension in starting for the 2nd day next day the simultaneously, totally 7 times, after whole body prime immunization completes, the attack of intranasal antigen is carried out in 2% ovalbumin normal saline solution instillation bilateral nostril by secondary daily microsyringe, every side 50 μ L, every day 1 time, continuous 5d, cause each group of AR model,
normal group adds 30mg aluminium hydroxide with 1ml normal saline and carries out the first sensitizing injection of the sufficient sole of the foot, strengthens sensitization and lumbar injection, then excites with normal saline collunarium (bilateral), and time, dosage are the same.
, administration
normal group: extract 50 μ L normal saline with microsyringe and carry out administration in the mode of collunarium, every side 25 μ L, every day 2 times, the morning and each 1 time of afternoon, continuous 7 days;
model group: extract 50 μ L normal saline with microsyringe and carry out administration in the mode of collunarium, every side 25 μ L, every day 2 times, the morning and each 1 time of afternoon, continuous 7 days;
blank group: according to the blank medication of experimental technique of the present invention when not adding Herba Achilleae extract, Radix Scutellariae extract and Radix Glycyrrhizae extract, extract the blank medication of 50 μ L with microsyringe and carry out administration in the mode of collunarium, every side 25 μ L, every day 2 times, the morning and each 1 time of afternoon, continuous 7 days;
positive controls: extract 50 μ L dexamethasone ephedrines with microsyringe and carry out administration in the mode of collunarium, every side 25 μ L, every day 2 times, the morning and each 1 time of afternoon, continuous 7 days;
high dose group: rhinitis of the present invention/allergic rhinitis liquid preparation being concentrated into volume is after 0.5 times of original volume, extracts 50 μ L and carries out administration in the mode of collunarium, every side 25 μ L with microsyringe;
middle dosage group: extract 50 μ L with microsyringe and rhinitis of the present invention/allergic rhinitis liquid preparation is carried out administration in the mode of collunarium, every side 25 μ L;
low dose group: rhinitis of the present invention/allergic rhinitis liquid preparation being diluted with water to volume is after 2 times of original volume, extracts 50 μ L and carries out administration in the mode of collunarium, every side 25 μ L with microsyringe.
30min after every morning administration, drip bilateral nostril, each 50 μ L in every side with the ovalbumin normal saline solution that mass concentration is 2%, bilateral equal-volume instills, and administration in afternoon no longer carries out nose antigen stimulation.
, nose allergic symptom observes: after each nose excites, observe 30min immediately.Observe sniffle as rhinocnesmus scratching, sneeze, watery nasal discharge.
, collection of specimens and process
5.5.1, gather: 7 groups of rat mass concentrations are that after chloral hydrate (0.3ml/100g) anesthesia of 10%, ventral aorta blood sampling is about 5ml to 6ml, deposit in test tube.
, serum preparation: get placement naturally under standby sample of blood liquid room temperature, after 2 hours with the rotating speed of 3000rpm centrifugal 10 minutes, pipette serum with micropipettor, put into Eppendoff pipe, be placed in-20 DEG C and save backup.Adopt rat immunoglobulin E and rat specific IgE to measure, by the operation of test kit description, measure by microplate reader, calculate the content of rat blood serum IgE, ovalbumin specific IgE and IL-4 according to respective standard curve.
, nasal mucosa collection: get blood complete, after ventral aorta blood-letting is lethal, peel off nose surrounding skin at once, upper jaw bone is dissociated out from skull, fix by 10% formalin, paraffin embedding, does HE and Toluidine blue staining, light Microscopic observation nasal mucosa, mastocyte and cell infiltration situation.
, statistical method: statistical method: adopt SPSS software to add up, variable data, with representing, compares between organizing, do t inspection, experimental result, in Table 4(, is divided,
n=6); Observe sniffle as: time that rhinocnesmus scratching, sneeze, watery nasal discharge etc. occur and weight and by following standards of grading and scoring record: rhinocnesmus: be slightly 1 point, dabbing nose is 2 points several times, and severe (scratching nose, face incessantly, scouring everywhere) is 3 points.Sneeze: 1 to 3 is 1 point, 4 to 10 is 2 points, and more than 11 is 3 points.Watery nasal discharge: flowing to anterior nares is 1 point, exceeding anterior nares is 2 points, and it is 3 points that tears stream is had one's face covered with, and remembers total score during record with the addition method.Adopt symptom integral superposition methods of marking (judging see model), compare group difference.
, result of the test
5.6.1, rat nose allergic symptom is observed and scoring
after nose instillation ovalbumin solution, observe 30min immediately, record rat scratches the symptoms such as nose, sneeze, rhinorrhea, and marks.Along with the number of times of ovalbumin challenge increases, the sniffle of rat increases the weight of gradually, and the symptom superposition drawn according to standards of grading is greater than 5 points, then modeling success is described.Normal group gives normal saline, without obvious sniffle, compares with model group, high dose group and positive controls all can significantly improve sniffle (
p<0.01), low, middle dosage group also can make moderate progress to the sniffle of rat, illustrates that rhinitis of the present invention/allergic rhinitis liquid preparation has good therapeutic effect to contingency rhinitis and allergic rhinitis, the results are shown in Table 7(, point,
n=10).
, each group allergic rhinitis rats serum immune globulin E and specific IgE comparision contents
the content of model group rats SERUM IgE and sIgE be significantly higher than Normal group (
p<0.01); Middle and high dosage group SERUM IgE content compares with positive controls, there was no significant difference (
p>0.05); High, medium and low administration group serum sIgE content compares with positive controls, the equal indifference opposite sex (
p>0.05), can find out, rhinitis of the present invention/allergic rhinitis liquid preparation has obvious antiinflammatory, anti-allergic effects, the results are shown in Table 8(
n=10).
rhinitis of the present invention/allergic rhinitis liquid preparation is on the impact of Rat Nasal Mucosa histopathology
rats in normal control group nasal mucosal tissue structural integrity, inorganization edema (see Figure 15), without inflammatory cell infiltration (see Figure 22); Model group nasal mucosal tissue exuviation, necrosis, lamina propria vasodilation, hyperemia, glandular hyperplasia, tissue edema (see Figure 16), eosinophilic granulocyte, mastocyte and other cell infiltration (see Figure 23); Blank group nasal mucosa situation similar to model group (see Figure 17, Figure 24); The nasal mucosal tissue structure recovery of positive controls rat reduces to more complete state, blood vessel is slight dilatation and congestion, glandular hyperplasia, organizes Mild edema (see Figure 18), and have a small amount of inflammatory cell infiltration, epithelial cell shedding reduces (see Figure 25); Low, middle dosage group, the congestion of blood vessel expansion of AR Rat Nasal Mucosa also various degrees, glandular hyperplasia and inflammatory cell infiltration, tissue edema obtains certain alleviation, but improve not as positive controls group obviously (see Figure 19, Figure 20, Figure 26, Figure 27); The nasal mucosal tissue structure recovery of high dose group rat is to more complete state, and slight tissue edema, still visible minority thin vessels expansion, after treating with positive controls suitable (see Figure 21, Figure 28).
this liquid preparation rat each experimental group nasal mucosa histopathologic slide adds up from edema, hyperemia, inflammatory cell and mast cells infiltration situation, and result shows, Normal group total score compares with model group, have significant difference (
p<0.01); High, medium and low dosage group total score compares with model group, have significant difference (
p<0.01); High, medium and low dosage group total score compares with positive controls, difference that there are no significant (
p>0.05) in Table 9(
n=10), can find out, rhinitis of the present invention/allergic rhinitis liquid preparation has obvious antiinflammatory, anti-allergic effects.
this shows: rhinitis of the present invention/allergic rhinitis liquid preparation is stable and controllable for quality, curative effect is obvious, owing to being pure Chinese medicinal preparation, therefore have no side effect, medicine directly acts on nasal mucosal surface, bioavailability is high, rapid-action, easy to use, patient compliance is good, and has good antiinflammatory, anti-allergic effects for rhinitis/allergic rhinitis.
。
Claims (6)
1. rhinitis/allergic rhinitis liquid preparation, is characterized in that the water for injection containing Radix Scutellariae extract 10g to 20g, Herba Achilleae extract 10g to 20g, Radix Glycyrrhizae extract 5g to 11 g, solubilizing agent 1g to 7 g, thickening agent 0.5g to 3.5 g, antiseptic 0.02g to 0.20 g and surplus in every 100ml rhinitis/allergic rhinitis liquid preparation, wherein, this rhinitis/allergic rhinitis liquid preparation obtains as follows: the water for injection of surplus comprises shot water and biphasic injection water, first respectively the solubilizing agent of aequum and thickening agent are dissolved in shot water and obtain solubilizer solution and thickener soln respectively, carry out centrifugal after Herba Achilleae extract solubilizer solution is dissolved, get supernatant, in supernatant, add Radix Scutellariae extract and Radix Scutellariae extract is dissolved completely, then thickener soln mix homogeneously is added wherein, add Radix Glycyrrhizae extract stirring more wherein to dissolve, then the antiseptic of aequum is added wherein, rhinitis/allergic rhinitis liquid preparation is obtained after finally adding biphasic injection water mix homogeneously wherein after abundant stirring and dissolving, wherein:
Herba Achilleae extract obtains by following preparation method: carry out alcohol extraction 1 time to 5 times by adding ethanol water in Herba Achilleae medical material, each alcohol extraction by add in every gram of Herba Achilleae medical material mass concentration be 30% to 95% ethanol water 6ml to 14ml in Herba Achilleae medical material, add ethanol water, time of each alcohol extraction is 0.5 little of 3 hours, alcohol extraction temperature is 60 DEG C to 80 DEG C, merge the alcohol extract at every turn obtained and obtain alcohol extraction conjunction liquid, then alcohol extraction is closed liquid and carry out ethanol volatilization, it is 40 DEG C to 70 DEG C in temperature that liquid is closed in alcohol extraction after ethanol volatilization, pressure is carry out drying under reduced pressure under the condition of-0.07 Mpa to-0.09Mpa to obtain the Herba Achilleae extract that biodiversity content is 5% to 20%, solubilizing agent is sodium bicarbonate or sodium hydroxide, thickening agent is methylcellulose or Carbopol or carboxymethyl cellulose, antiseptic is Nipagin ester, during use, first Nipagin ester is dissolved in dehydrated alcohol and obtains Nipagin ester ethanol solution, then use.
2. rhinitis according to claim 1/allergic rhinitis liquid preparation, is characterized in that Radix Scutellariae extract obtains by the preparation method described in the Radix Scutellariae extract in Chinese Pharmacopoeia version first in 2010; Or/and the preparation method described in Radix Glycyrrhizae extractum in Radix Glycyrrhizae extract Chinese Pharmacopoeia version first in 2010 obtains.
3. a preparation method for rhinitis/allergic rhinitis liquid preparation, is characterized in that the water for injection containing Radix Scutellariae extract 10g to 20g, Herba Achilleae extract 10g to 20g, Radix Glycyrrhizae extract 5g to 11 g, solubilizing agent 1g to 7 g, thickening agent 0.5g to 3.5 g, antiseptic 0.02g to 0.20 g and surplus in every 100ml rhinitis/allergic rhinitis liquid preparation, wherein, the preparation method of this rhinitis/allergic rhinitis liquid preparation is carried out in the steps below: the water for injection of surplus comprises shot water and biphasic injection water, first respectively the solubilizing agent of aequum and thickening agent are dissolved in shot water and obtain solubilizer solution and thickener soln respectively, carry out centrifugal after Herba Achilleae extract solubilizer solution is dissolved, get supernatant, in supernatant, add Radix Scutellariae extract and Radix Scutellariae extract is dissolved completely, then thickener soln mix homogeneously is added wherein, add Radix Glycyrrhizae extract stirring more wherein to dissolve, then the antiseptic of aequum is added wherein, rhinitis/allergic rhinitis liquid preparation is obtained after finally adding biphasic injection water mix homogeneously wherein after abundant stirring and dissolving, wherein:
Herba Achilleae extract obtains by following preparation method: carry out alcohol extraction 1 time to 5 times by adding ethanol water in Herba Achilleae medical material, each alcohol extraction by add in every gram of Herba Achilleae medical material mass concentration be 30% to 95% ethanol water 6ml to 14ml in Herba Achilleae medical material, add ethanol water, time of each alcohol extraction is 0.5 little of 3 hours, alcohol extraction temperature is 60 DEG C to 80 DEG C, merge the alcohol extract at every turn obtained and obtain alcohol extraction conjunction liquid, then alcohol extraction is closed liquid and carry out volatilization ethanol, it is 40 DEG C to 70 DEG C in temperature that liquid is closed in alcohol extraction after volatilization ethanol, pressure is carry out drying under reduced pressure under the condition of-0.07 Mpa to-0.09Mpa to obtain the Herba Achilleae extract that biodiversity content is 5% to 20%, solubilizing agent is sodium bicarbonate or sodium hydroxide, thickening agent is methylcellulose or Carbopol or carboxymethyl cellulose, antiseptic is Nipagin ester, during use, first Nipagin ester is dissolved in dehydrated alcohol and obtains Nipagin ester ethanol solution, then use.
4. the preparation method of rhinitis according to claim 3/allergic rhinitis liquid preparation, is characterized in that Radix Scutellariae extract obtains by the preparation method described in the Radix Scutellariae extract in Chinese Pharmacopoeia version first in 2010; Or/and the preparation method described in Radix Glycyrrhizae extractum in Radix Glycyrrhizae extract Chinese Pharmacopoeia version first in 2010 obtains.
5. one kind adopts the application of rhinitis/allergic rhinitis liquid preparation in preparation treatment rhinitis/allergic rhinitis object space face described in claim 1 or 2.
6. rhinitis according to claim 5/allergic rhinitis liquid preparation is in the application in preparation treatment rhinitis/allergic rhinitis object space face, it is characterized in that this treatment rhinitis/allergic rhinitis medicine is drop or injectant or detergent.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310197676.XA CN103271993B (en) | 2013-05-24 | 2013-05-24 | Liquid preparation for rhinitis/allergic rhinitis as well as preparation method and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310197676.XA CN103271993B (en) | 2013-05-24 | 2013-05-24 | Liquid preparation for rhinitis/allergic rhinitis as well as preparation method and application thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103271993A CN103271993A (en) | 2013-09-04 |
| CN103271993B true CN103271993B (en) | 2015-06-17 |
Family
ID=49054241
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310197676.XA Active CN103271993B (en) | 2013-05-24 | 2013-05-24 | Liquid preparation for rhinitis/allergic rhinitis as well as preparation method and application thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103271993B (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107412331B (en) * | 2017-09-14 | 2021-02-12 | 新疆维吾尔自治区药物研究所 | Nasal preparation for treating rhinitis and preparation method and application thereof |
| TWI676479B (en) * | 2018-08-14 | 2019-11-11 | 長庚醫療財團法人嘉義長庚紀念醫院 | Use of glycyrrhiza extract in preparation of medicament for treatment of nasal inflammation and pharmaceutical composition including the same |
| CN111317719A (en) * | 2018-12-13 | 2020-06-23 | 复旦大学 | Artemisia rupestris nasal spray with antiviral activity |
| CN112156073A (en) * | 2020-09-07 | 2021-01-01 | 厦门市壳聚糖生物科技有限公司 | Hydrogen-rich physiological seawater nasal spray and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102370954A (en) * | 2010-08-09 | 2012-03-14 | 陈新泉 | Medicine for treating chronic rhinitis |
-
2013
- 2013-05-24 CN CN201310197676.XA patent/CN103271993B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102370954A (en) * | 2010-08-09 | 2012-03-14 | 陈新泉 | Medicine for treating chronic rhinitis |
Non-Patent Citations (4)
| Title |
|---|
| 《芩蒿滴鼻剂中一枝蒿抗炎有效成分的提取工艺研究》;杨国萍等;《新疆医科大学学报》;20130115;第47-51页 * |
| 《芩蒿滴鼻剂对变应性鼻炎大鼠疗效的实验研究 》;董先红等;《新疆医科大学学报》;20130315;第321-324页 * |
| 张兆旺.《附录:药剂常用辅料》.《中药药剂学》.2003, * |
| 杨国萍.《芩蒿滴鼻液的制备及质量标准研究》.《新疆医科大学硕士论文》.2013, * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN103271993A (en) | 2013-09-04 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101530473A (en) | Nose-dredging spraying agent and preparation method thereof | |
| CN103271993B (en) | Liquid preparation for rhinitis/allergic rhinitis as well as preparation method and application thereof | |
| CN105343625A (en) | Taraxacum oral liquid for expelling toxin, dehumidifying and benefiting gallbladder and preparation method thereof | |
| CN103751663B (en) | A kind of Chinese medicine for external application treating anal eczema and preparation method thereof | |
| CN1931247B (en) | Medicine for treating rhinitis and its preparation process | |
| CN103520593B (en) | Chinese herba preparation for treating trichomonas vaginitis and preparation method thereof | |
| CN102920915A (en) | Ointment preparation for treating haemorrhoids and preparation method for ointment preparation | |
| CN1327875C (en) | Chinese medicine formulation for treating chronic pelvic inflammation and its preparing method | |
| CN100353996C (en) | Medicine composition for treating soft tissue damage and osteoarthropathy and its prepn process | |
| CN103735845B (en) | A kind of Chinese medicine for external application treating Pediatric secretory otitis media and preparation method thereof | |
| CN105412605A (en) | Traditional Chinese medicine mask capable of promoting blood circulation, beautifying and removing freckles and preparation method thereof | |
| CN105056128B (en) | A kind of Chinese medicine composition and preparation method and application for treating atrophic gastritis and intestines | |
| CN108403932B (en) | Traditional Chinese medicine compound external preparation for treating hormone-dependent dermatitis and preparation method and application thereof | |
| CN103405615B (en) | TCM (Traditional Chinese Medicine) composition for invigorating kidney and strengthening Yang and preparation method of TCM composition | |
| CN103830355B (en) | Oleum Nigellae nasal drop and preparation method thereof | |
| CN103721138B (en) | A kind of traditional Chinese medicine for external application and its preparation method treating rosacea | |
| CN103181961A (en) | Preparation method of flavonoid medicine for treating frostbite | |
| CN103405614B (en) | TCM (Traditional Chinese Medicine) composition for invigorating kidney and strengthening Yang and preparation method of TCM composition | |
| CN104673495B (en) | The extracting method of volatile oil and application in a kind of selfheal for preventing and treating gynaecological imflammation | |
| CN105343847A (en) | Traditional Chinese medicine composition for treating eczema containing folium artemisiae argyi and preparing method thereof | |
| CN108324829A (en) | A kind of Hemorrhagic shock mixture and preparation method thereof containing ginseng | |
| CN109248269A (en) | A kind of traditional Chinese medicine for outer use for treating hyperplasia of mammary glands | |
| CN114748527B (en) | Compound gentian gel for treating infant eczema and dermatitis | |
| CN103251719B (en) | Traditional Chinese medicine composition (toxin-expelling and skin-beautifying capsule) and preparation method thereof | |
| CN103405618B (en) | A kind of Chinese medicine composition of kidney invigorating and YANG supporting and preparation and determination methods method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |